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Guardant Health Announces Approval in Europe of Guardant360® CDx as Companion Diagnostic for AstraZeneca’s ETCAMAH™ (camizestrant) in Advanced ER-positive Breast Cancer

Thursday, October 8, 2026 BiopharmaWatch Research 1 min read
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Key Takeaway: Guardant Health has announced that its Guardant360® CDx has received CE-marking approval in Europe. This diagnostic tool is designed to identify patients with ER-positive, HER2-negative locally advanced or metastatic breast cancer who may benefit from AstraZeneca's ETCAMAH™ (camizestrant). This approval marks a significant step in precision oncology for breast cancer treatment.

Market Sentiment Analysis

POSITIVE FACTORS

  • Guardant360® CDx received CE-marking approval in Europe.
  • It serves as a companion diagnostic for a new cancer treatment.
  • The diagnostic targets a specific patient population with advanced breast cancer.

Full Press Release Details

PALO ALTO, Calif.--(BUSINESS WIRE)--Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced that Guardant360® CDx has received CE-marking under Europe’s in Vitro Diagnostic Medical Devices Regulation as a companion diagnostic (CDx) to identify patients with estrogen receptor (ER)-positive, HER2-negative locally advanced or metastatic breast cancer who may benefit from treatment with ETCAMAH™ (camizestrant), AstraZeneca’s next-generation oral selective estrogen

Frequently Asked Questions

What is Guardant360® CDx?

Guardant360® CDx is a companion diagnostic tool used to identify patients with specific types of breast cancer.

What does CE-marking signify?

CE-marking indicates that a product meets European safety and efficacy standards for medical devices.

Who benefits from ETCAMAH™ treatment?

Patients with ER-positive, HER2-negative locally advanced or metastatic breast cancer may benefit from ETCAMAH™.

Which company developed ETCAMAH™?

ETCAMAH™ (camizestrant) is developed by AstraZeneca.

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Tags: GH Guardant Health Guardant360 ETCAMAH breast cancer AstraZeneca
Last updated: Oct 8, 2026

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